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NCT07343986 · ClinicalTrials.gov registry record · Phase 1

Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma

A Phase 1 study of Glioblastoma (GBM), sponsored by University of Virginia.

Recruiting
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT07343986 is a Phase 1 study of Glioblastoma (GBM) that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 12 participants, below the 85-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07343986, a Phase 1 study of Glioblastoma (GBM), is actively recruiting participants, sponsored by University of Virginia.

RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-intensity focused ultrasound would induce blood-brain barrier opening and increase the permeability of the adoptive immunotherapy. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.

Conditions Studied

Glioblastoma (GBM)

Interventions

  • DEVICE Low-Intensity Focused Ultrasound
  • DRUG anti-EGFR bispecific-armed T cells

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2026-01
Est. Completion 2028-12
Phase Phase 1

Sponsor

University of Virginia

449 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07343986

The ClinicalTrials.gov registry entry for NCT07343986 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (86% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Glioblastoma (GBM) appearing as the primary indexed condition, and to 2 interventions - of which Low-Intensity Focused Ultrasound is the first listed.

NCT07343986 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT07343986 about?

NCT07343986 is a clinical study titled "Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma". This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-int...

What is the current status of trial NCT07343986?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-01. Estimated completion is 2028-12.

What conditions does trial NCT07343986 study?

This clinical trial studies the following conditions: Glioblastoma (GBM).

What interventions are being tested in trial NCT07343986?

The interventions under investigation include: Low-Intensity Focused Ultrasound (DEVICE), anti-EGFR bispecific-armed T cells (DRUG).

Who is sponsoring clinical trial NCT07343986?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07343986 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.